• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

  • Print
  • Share
  • E-mail
Pediatric Labeling Date:  03/11/2005
Trade Name:  Rapamune
Generic Name or Proper Name (*):  sirolimus
Indications Studied:  Prophylaxis of organ rejection in patients undergoing renal transplants
Label Changes Summary:  * Safety and efficacy established in children 13 years or older judged to be at low to moderate immunologic risk * Safety was assessed in a controlled clinical trial in pediatric (<18 years of age) renal transplant recipients considered high immunologic risk. The use of Rapamune in combination with calcineurin inhibitors and corticosteroids was associated with an increased risk of deterioration of renal function, lipid abnormalities, and urinary tract infections * Safety and efficacy have not been established in pediatric patients less than 13 years old or in pediatric renal transplant recipients considered at high immunologic risk * Information on PK parameters, adverse events and safety
Product Labeling:  Labeling  Opens a new window
Sponsor:  Wyeth
Pediatric Exclusivity Granted Date:  11/17/2004
Therapeutic Category:  Immunosuppressant